Clinical trials: Inflammatory Myelopathies
Poliomyelitis
A Post-marketing Safety Study of GSK Bio IPV Vaccine (PoliorixTM) in Korean Children
Following licensing of PoliorixTM in Korea, this study will collect safety data about the routine use of this vaccine in 600 children according to the regulations of Korean Food and Drugs Administration (KFDA).
- Trial name
- NCT00514033
- Testing
- Poliomyelitis vaccine (inactivated) -PoliorixTM
- Where
- South Korea
- Volunteers
- 349 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acellular Pertussis, Tetanus
Immunogenicity and Safety Study of Infanrix Hexa in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women who participated in study 116945 [DTPA…
- Conditions
- Acellular Pertussis, Tetanus, Poliomyelitis, Diphtheria
- Trial name
- NCT02422264
- Testing
- Infanrix hexa, Prevnar13
- Where
- 30 sites in Australia, Canada and 4 more
- Volunteers
- 601 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acellular Pertussis, Diphtheria
Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children in Korea
The purpose of this study is to collect safety information following routine vaccination with Infanrix-IPV among infants and children in Korea.
- Conditions
- Acellular Pertussis, Diphtheria, Tetanus, Poliomyelitis
- Trial name
- NCT01568060
- Testing
- Infanrix-IPV data collection
- Where
- South Korea
- Volunteers
- 645 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series
The purpose of this study is to evaluate immunogenicity and safety of different doses of candidate hexavalent vaccine in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT05457946
- Testing
- LBVD (Hexavalent vaccine), Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- LG Chem
Diphtheria, Tetanus
Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine
This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines. Stage I Primary Objectives: 1.
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Polio
- Trial name
- NCT00662870
- Testing
- DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine), Pentacel: DTaP-IPV/Hib
- Where
- 26 sites in United States
- Volunteers
- 1,941 people, healthy volunteers welcome
- Sponsor
- Sanofi
Diphtheria, Tetanus
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants
The study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP~T vaccine has immunological and safety profiles that are comparable to those of the control vaccine that is already marketed…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00831753
- Testing
- DTaP IPV HB PRP~T vaccine, DTaP-HB-IPV and Haemophilus influenzae type b
- Where
- Peru
- Volunteers
- 263 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Neuromyelitis Optica Spectrum Disorder
A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
This multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optica spectrum disorder (NMOSD) who completed open-label extension (OLE) period of…
- Trial name
- NCT04660539
- Testing
- satralizumab, azathioprine (AZA), mycophenolate mofetil (MMF)
- Where
- 53 sites in United States, Bulgaria and 16 more
- Volunteers
- 119 people
- Sponsor
- Hoffmann-La Roche
Neuromyelitis Optica Spectrum Disorder, NMOSD
Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies
Long-term, multicenter, multinational, observational, registry of patients with AQP4+ NMOSD that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT).
- Conditions
- Neuromyelitis Optica Spectrum Disorder, NMOSD, AQP4+ NMOSD
- Trial name
- NCT05966467
- Where
- 33 sites in United States, Argentina and 6 more
- Volunteers
- 200 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Poliomyelitis, Diphtheria
Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine
Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will be evaluated in terms of immunogenicity, safety…
- Conditions
- Poliomyelitis, Diphtheria, Tetanus, Acellular Pertussis
- Trial name
- NCT00635128
- Testing
- Boostrix-Polio
- Where
- 38 sites in Germany
- Volunteers
- 415 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Diphtheria
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately
This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix…
- Conditions
- Hepatitis B, Diphtheria, Haemophilus Influenzae Type b (Hib), Poliomyelitis
- Trial name
- NCT01457508
- Testing
- DTPa-HBV-IPV/Hib (Infanrix hexa™), DTPa-HBV-IPV (Infanrix penta™), Hib (Hiberix™)
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
A Study to Compare LBVD to Eupenta and Imovax Polio in Healthy Adults
This is a single-center, randomized, active-controlled, parallel-group, open-label, phase I study to evaluate safety and immunogenicity of single injection of LBVD or Eupenta co-administered with Imovax Polio in healthy adults.
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT03208101
- Testing
- DTP-HepB-IPV-Hib vaccine, DTP-HepB-Hib vaccine & IPV
- Where
- South Korea
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- LG Chem
Diphtheria, Tetanus
DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants
This study aims to assess and confirm the adequate immunogenicity and safety profile of the Sanofi Pasteur's DTaP-Hep B-IPV-PRP-T fully liquid combined hexavalent vaccine administered in HIV-exposed uninfected infants and in…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT02817451
- Testing
- Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine
- Where
- South Africa
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Neuromyelitis Optica Spectrum Disorders
A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Neuromyelitis Optica Spectrum Disorders.
- Trial name
- NCT03330418
- Testing
- RC18 160 mg
- Where
- China
- Volunteers
- 178 people
- Sponsor
- RemeGen Co., Ltd.
Progressive Multiple Sclerosis, Neuromyelitis Optica.
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica
Multiple sclerosis (MS) has been classically regarded as a chronic inflammatory autoimmune demyelinating disease of the central nervous system, along with a considerable pathological heterogeneity.
- Trial name
- NCT01364246
- Testing
- human umbilical cord mesenchymal stem cells
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.
Diphtheria, Tetanus
Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS
The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV combination vaccine compared with those of separate DTaP and IPV vaccines administered to healthy infants at 2, 4, and 6 months of age.
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- Venus (NCT02458183)
- Testing
- DTaP-IPV combination vaccine, DTaP vaccine and IPV vaccine
- Where
- 20 sites in South Korea, Thailand
- Volunteers
- 476 people, healthy volunteers welcome
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Bacterial Infections, Virus Diseases
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine.
- Trial name
- NCT01480258
- Testing
- PR5I, Rotavirus vaccine, Prevenar 13™
- Volunteers
- 1,315 people, healthy volunteers welcome
- Sponsor
- MCM Vaccines B.V.
Pertussis, Diphtheria
Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV
The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTaP-IPV combined vaccines as a three-dose primary vaccination at 2, 4 and 6 months of age compared to commercially available…
- Conditions
- Pertussis, Diphtheria, Poliomyelitis, Tetanus
- Trial name
- NCT00319852
- Testing
- DTaP-IPV combined vaccine, DTaP vaccine
- Where
- South Korea
- Volunteers
- 442 people, healthy volunteers welcome
- Sponsor
- Sanofi
Diphtheria, Hepatitis B
Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants
In this study, infants will be randomly allocated into three groups: one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation) the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current…
- Conditions
- Diphtheria, Hepatitis B, Poliomyelitis, Tetanus
- Trial name
- NCT00320463
- Testing
- DTPa-HBV-IPV/Hib vaccine
- Where
- 4 sites in Russia
- Volunteers
- 415 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
Primary Objective: To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00831311
- Testing
- DTaP-IPV-HB-PRP~T, DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
- Where
- Argentina
- Volunteers
- 624 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Acellular Pertussis
Evaluation of Immunogenicity and Safety of DTPa-IPV/Hib Conjugate Vaccine (Infanrix™-IPV/Hib) Administered at 6, 10 and 14 Weeks in Healthy Indian Infants
The purpose of this study is to assess the immunogenicity and safety of DTPa-IPV/Hib when administered at 6, 10 and 14 weeks to healthy Indian infants, as per guidance from the Indian regulatory authority.
- Conditions
- Diphtheria, Acellular Pertussis, Haemophilus Influenzae Type b, Tetanus
- Trial name
- NCT03128489
- Testing
- Infanrix-IPV/Hib
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline